Biostatistical Programming Senior Associate (Innovation)
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Biostatistical Programming Senior Associate ( Innovation)
HOW MIGHT YOU DEFY IMAGINATION
Join us.
Biostatistical Programming Senior Associate (Innovation)
NOTE: THIS ROLE DIFFERS FROM A TRADITIONAL STATISTICAL PROGRAMMING POSITION.
What you will do
Lets do this. Lets change the world.
Amgen is expanding its global Statistical Programming capabilities, with Amgen India (AIN) playing a key role in supporting integrated delivery across regions. As a Biostatistical Programming Senior Associate, you will focus on developing programming efficiencies, automation solutions, and innovative tools that enhance productivity and scalability across programming teams. This position is ideal for candidates who enjoy building systems and optimizing workflowsnot for those primarily seeking to perform hands on statistical programming activities to support complex statistical data analysis of clinical studies and regulatory submissions.
Key Responsibilities:
- Analysis and reporting of clinical trial data using SAS and/or R or Python
- Creation and validation of complex SDTM, ADaM, and other analysis datasets, both safety and efficacy
- Creation and validation of complex tables, listings, and figures, both safety and efficacy
- Prepare statistical programming specifications
- Prepare statistical programming related documents for regulatory submissions
- Maintain tracking and validation documentation
- Collaborate with cross-functional team and create and/or validate complex programs for checking data quality
- Interact and collaborate with study team members from other functions globally
- Assist in some of the tasks of the Study Lead Programmer (SLP) or serve as a backup SLP
- Design, build, and maintain programming solutions and tools that improve efficiency and quality across statistical programming ecosystems.
- Contribute to the full development lifecyclefrom requirements gathering and design through testing, deployment, and maintenance.
- Collaborate with programming teams across center for design and analysis (CfDA) to identify process gaps and prototype scalable solutions using modern programming practices.
- Support federated innovationintegrating ideas and code contributions from other programming teams into unified, CfDA-wide solutions.
- Automate repeatable programming tasks and establish standards for modular, reusable code.
- Leverage AI and machine learning capabilities, including developing and deploying AI agents or copilots, to optimize programming workflows and knowledge sharing.
- Create and maintain clear, version-controlled documentation, training materials, and user guides to enable sustainable adoption of new tools.
- Participate in ongoing evaluation and enhancement of tools, ensuring continued performance, security, and relevance.
- Collaborate with cross-functional partners to align innovations with business needs and technical standards.
This position will be located at Amgen India (Hyderabad).
Win
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The professional we seek is a results-oriented, tech-forward programming leader with deep expertise in clinical trial operations and digital transformation.
Basic Qualifications:
- Bachelorsor higher degree in biostatistics, statistics, mathematics, AI and data science, computer science, or other related quantitative or scientific subjects, with at least 4 years of statistical programming experience in relevant career statistical programming experience in a clinical development environment.
- Familiarity with drug development life cycle and excellent skills with the manipulation, analysis and reporting of complex clinical trial data
- Ability to effectively perform complex statistical programming and related tasks
- Ability to provide quality output and deliverables in adherence with challenging timelines
- Ability to work effectively on multiple tasks or projects across therapeutic areas
- Ability to work effectively and successfully in a globally dispersed team environment with cross-cultural partners
- Working knowledge of latest CDISC SDTM standards and familiar with CDISC ADaM and Define standards with strong ability to implement the standards
- Familiar with data quality and compliance check tools
- Excellent oral and written English communication skills
Preferred Skills:
- Masters or higher degree in statistics, biostatistics, mathematics, AI and data science, computer science or related quantitative or scientific subjects
- Familiarity with open-source programming tools (R, Python), automation platforms, and emerging technologies in statistical programming
- Experience developing or maintaining solutions through a structured software development lifecycle (SDLC).
Experience:
- SAS macro development
- R/Python Package development
- Working knowledge of version control (e.g., Git) and collaborative coding practices.
- Familiarity with AI and machine learning frameworks (e.g., OpenAI API, or custom model training).
- Building or implementing AI-driven programming assistants, copilots, or agents for workflow optimization.
- Working knowledge of Agile project management and collaborative development environments.
Competencies:
- Strong programming (e.g., SAS, R, SQL, Python) and analytic skills
- Innovation and problem solving
- Strong documentation and communication skills
- Collaboration and teamwork across functions
- Organization and follow-through in structured projects
- AI and automation mindset
- Learning agility and curiosity
Thrive
What you can expect of us
As we work to develop treatments that take care of others, so we work to care for our teammates professional and personal growth and well-being.
- Vast opportunities to learn and move up and across our global organization
- Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
- Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits